The present invention is directed to orthopedic devices, and more particularly to orthotic support devices for assisting in the stabilization and proper healing of ulcerative conditions, especially for diabetic patients suffering from diabetic foot ulcers.
Some diabetics suffer from ulcerations, infections, and gangrene. Diabetic patients suffering from ulcerations, infections, and gangrene might require limb amputation. The present invention benefits these patients because it minimizes the pressure placed on certain areas of the plantar areas of the foot.
Many diabetics suffer from distal symmetric polyneuropathy. Distal symmetric polyneuropathy is perhaps the most common complication affecting the lower extremities of patients with diabetes mellitus. The polyneuropathy, the lack of protective sensation, combined with un-accommodated foot deformities, exposes diabetics to undue sudden or repetitive stress that leads to eventual ulcer formation with a risk of infection and possible amputation of the lower extremities.
Three basic issues need to be addressed to successfully treat diabetic foot ulcers: debridement, offloading, and infection control.
The present invention addresses the issue of offloading. Offloading is defined as the complete halting of weight bearing on an affected foot. Using the present invention, weight bearing shall be minimized to the ulcerous areas of the affected foot. At the present time, the most effective methods of offloading are through patients' use of wheelchairs or crutches.
The problem with using the above methods of offloading is that some diabetic patients are accustomed to having active lifestyles. They are used to being on the go and do not believe they have time to use wheelchairs or crutches. Some of these active individuals suffer from polyneuropathy, thus they do not experience the pain associated with the ulcers and thereby tend to not realize the damage they are causing the ulcerous areas of the foot. Eventually, some of these individuals develop wounds that are un-healable and that thereby lead to amputation of the affected areas.
Some patients treated using the methods described above almost recover fully. They do not fully recover prior to completion of treatment, because of the polyneuropathy that they suffer, they convince themselves that they are cured and continue their daily activities. By continuing their daily activities, they re-aggravate their wounds and thereby commence vicious cycles of recovery and re-aggravation that eventually lead to wounds that are un-healable.
Devices currently used to relieve pressure from ulcerated wounds include shoes having special soles that may or may not stabilize the foot. The soles define cutouts wherein ulcerated sections of the diabetic foot would lie. The problem using the above devices to treat the wounds is that the person using the shoes might sometimes step in an awkward fashion and thereby dislodge the foot from a first position, the position being where the wound would be within the cutout, to a second position, wherein the wound would be displaced from the Cutout section of the sole to a solid position of the sole. When the foot is in the second position, the patient being treated would aggravate the wound.
The inventor of the present invention suffers from diabetic foot ulcers and has invented a universal device that is to be worn on the exterior of most shoes. The device will have three points of contact with existing shoes. Most shoes have two major points of contact with the ground, the heel and the pad of the shoe. The present invention purposely establishes three points of contact between the shoe and the device. By establishing the third point of contact, the device shifts the weight from two specific points of contact to three points of contact. By creating a third point of contact, a specific section of a point of contact of the heel or the pad will be avoided.
The design of the device allows a wounded section of the a foot to be securely stabilized within a shoe while avoiding a specific point of contact between the shoe and the device. The shoe mounted on the device would ideally use a sole that would have a cutout for the ulcer to lie in. The section of the shoe having the cutout is prevented from bearing weight because of the device. The reason for this is that the section of the shoe having the cutout would be elevated by the three points of contact of the present invention.
For the foregoing reasons, there is a need for an orthotic device that minimizes weight bearing on certain areas of a shoe being worn by a diabetic suffering from a diabetic foot ulcer that will allow the patients to live active lifestyles while being treated for foot ulcerations.